Comparing 8 approaches for metastatic uveal melanoma

Exclusion

• −For patients receiving IDE196 powder-in-capsule (PIC) formulation or crizotinib, allergy to mammalian meat products and gelatin
• −Any contraindication associated to the use of statins or hypersensitivity component of pravastatin
• −Known symptomatic brain metastases
• −Known acquired immunodeficiency syndrome (AIDS)-related illness, hepatitis B virus, or hepatitis C virus
• −Previous treatment with a PKC inhibitor
• −Known MSI-H/dMMR tumors who have not previously received immune checkpoint inhibitors
• −Adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → from prior anti-cancer therapy that have not resolved
• −Active infection requiring ongoing therapy
• −Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect
• −Impaired cardiac function
• −Treatment with prohibited medications that cannot be discontinued prior to study entry
• −Crizotinib Combination Additional Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
• −Prior therapy directly targeting ALK, MET, or ROS1
• −Spinal cord compression
• −History of pneumonitis or interstitial lung disease
• −History of syncope
• −History of thromboembolic or cerebrovascular events ≤12 weeks prior to first dose of study treatment
• −PKPharmacokineticsThe study of how the body absorbs, distributes, and clears a treatment.Read more → Substudy (optional) with Pravastatin Additional Exclusion Criteria:
• −Taken any dose of statin or inhibitor of organic anion transporting polypeptide within 7 days prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in the study and cannot refrain from them through C2D1
• −Taken drugs that interfere with the absorption, metabolism, or elimination of pravastatin
• −Active liver disease
• −DDI Cocktail Substudy Additional Exclusion Criteria:
• −Treatment with bupropion, repaglinide, flurbiprofen, omeprazole, esomeprazole, midazolam, and dabigatran etexilate within 7 days prior to Cycle 1 Day -1.
• −Intake of vitamin supplements containing Vitamin B6 (pyridoxine), grapefruit/grapefruit juice, or Seville orange juice within 7 days prior to Cycle 1 Day -1.
• −Intake of any strong or moderate inhibitor of CYP2B6, CYP2CI, CYP2C9, CYP2C10 and OAT3 is prohibited within 7 days or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.
• −Moderate and strong inhibitors of CYP2A4/5 or P-gp are prohibited within 7 days, or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.
• −Intake of strong or moderate inducers of CYP3A4/5, CYP2B6, CYP2C9, CYP2C19, or OAT3 is prohibited during 15 days, or 5 half-lives, whichever is longer, prior to Cycle 1 Day -1.
• −Females who are pregnant or breastfeeding
• −Recent surgery or radiotherapy